[Bioethical issues on the access to drugs in the practice of ophthalmology in Colombia]. / Cuestiones bioéticas relacionadas con el acceso a medicamentos en el ejercicio de la oftalmología en Colombia.

Ophthalmology is a high-cost specialty in terms of medical, surgical and technological innovation and treatment. It is worrisome that in some countries patients are affected in their visual health, and therefore in their quality of life because they do not have the necessary resources for timely access to medications, medical appointments or surgical procedures. We searched in four electronic databases (ScienceDirect, MEDLINE/PubMed, ClinicalKey and SciELO), as well as in books on bioethics and Colombian laws, for articles related to bioethical issues and access to medicines in the exercise of ophthalmology. We reflect on the problem of access to ophthalmological drugs, with particular interest on how to apply the principles of bioethics on the clinical practice of patients with ophthalmological conditions. Ethical considerations are approached from the principles of Beauchamp and Childress, especially regarding the principle of justice, in order to provide health professionals in this field with arguments for medical and ethical decisions that benefit the healthcare and access to medicines for patients with ophthalmological conditions.

La oftalmología se constituye como una especialidad de alto costo en lo que respecta a tratamiento médico, quirúrgico y de innovación tecnológica. Es preocupante que en algunos países los pacientes se vean afectados en su salud visual, y por ende en su calidad de vida, por no contar con los recursos necesarios para un acceso oportuno a medicamentos, citas médicas o procedimientos quirúrgicos. A partir de la búsqueda de artículos relacionados con cuestiones bioéticas y el acceso a medicamentos en el ejercicio de la oftalmología en cuatro bases de datos electrónicas (ScienceDirect, MEDLINE/PubMed, ClinicalKey y SciELO ), así como en libros de bioética y leyes de la jurisdicción colombiana, realizamos una reflexión sobre el problema del acceso a los medicamentos oftalmológicos, centrándonos en el interés por la aplicación de la bioética en la práctica clínica y en el acceso a medicamentos de los pacientes con patologías oftalmológicas. Las consideraciones éticas se abordan desde una mirada del modelo principialista de Beauchamp y Childress, en especial considerando el principio de justicia, de modo que brinde a los profesionales de la salud en este campo, argumentos para la toma de decisiones médicas y éticas que beneficien la atención y el acceso a medicamentos de los pacientes con patologías oftalmológicas.

Health policy regulations pertaining to advanced surgical devices-their socio-economic effects on ophthalmology practice.

The Israel Ministry of Health enacted regulations that aim to reduce private expenditure on healthcare services and mitigate social inequality. According to the modified rules, which went into effect in the second half of 2016, patients who undergo surgery in a private hospital and are covered by their healthcare provider's supplemental insurance (SI) make only a basic co-payment.The modified regulations limited the option of self-payment for advanced devices not covered by national health basket, meaning that patients for whom such devices are indicated had to pay privately for the entire procedure. These regulations applied to all medical and surgical devices not covered by national health insurance (NHI).Toric intraocular lenses (IOLs) are a case in point. These advanced lenses are implanted during cataract surgery to correct corneal astigmatism and, in indicated cases, obviate the need for complex eyeglasses postoperatively. Toric IOL implantation has been shown to be highly cost-effective in both economic and quality-of-life terms. Limitations of the use of these advanced IOLs threatened to increase social inequality.In 2017, further adjustments of the regulations were made which enabled supplemental charges for these advanced IOLs, performed through the SI programs of the healthcare medical organizations (HMOs). Allowing additional payment for these lenses at a fixed pre-set price made it possible to apply a supplemental part of the insurance package to the surgery itself. In mid 2018 these IOLs were included without budget in the national health basket, allowing for self-payment for the additional cost in addition to the basic coverage for all patients with NHI.This case study suggests that, in their efforts to enhance health care equity, policymakers may benefit if exercising due caution when limiting the extent to which SI programs can charge co-payments. This is because, when a service or product is not available via the basic NHI benefits package, limiting SI co-payments can sometimes result in a boomerang effect - leading to an increase in inequality rather than the sought-after decrease in inequality.

Cuestiones bioéticas relacionadas con el acceso a medicamentos en el ejercicio de la oftalmología en Colombia / Bioethical issues on the access to drugs in the practice of ophthalmology in Colombia

Resumen La oftalmología se constituye como una especialidad de alto costo en lo que respecta a tratamiento médico, quirúrgico y de innovación tecnológica. Es preocupante que en algunos países los pacientes se vean afectados en su salud visual, y por ende en su calidad de vida, por no contar con los recursos necesarios para un acceso oportuno a medicamentos, citas médicas o procedimientos quirúrgicos. A partir de la búsqueda de artículos relacionados con cuestiones bioéticas y el acceso a medicamentos en el ejercicio de la oftalmología en cuatro bases de datos electrónicas (ScienceDirect, MEDLINE/PubMed, ClinicalKey y SciELO ), así como en libros de bioética y leyes de la jurisdicción colombiana, realizamos una reflexión sobre el problema del acceso a los medicamentos oftalmológicos, centrándonos en el interés por la aplicación de la bioética en la práctica clínica y en el acceso a medicamentos de los pacientes con patologías oftalmológicas. Las consideraciones éticas se abordan desde una mirada del modelo principialista de Beauchamp y Childress, en especial considerando el principio de justicia, de modo que brinde a los profesionales de la salud en este campo, argumentos para la toma de decisiones médicas y éticas que beneficien la atención y el acceso a medicamentos de los pacientes con patologías oftalmológicas.

Abstract Ophthalmology is a high-cost specialty in terms of medical, surgical and technological innovation and treatment. It is worrisome that in some countries patients are affected in their visual health, and therefore in their quality of life because they do not have the necessary resources for timely access to medications, medical appointments or surgical procedures. We searched in four electronic databases (ScienceDirect, MEDLINE/PubMed, ClinicalKey and SciELO), as well as in books on bioethics and Colombian laws, for articles related to bioethical issues and access to medicines in the exercise of ophthalmology. We reflect on the problem of access to ophthalmological drugs, with particular interest on how to apply the principles of bioethics on the clinical practice of patients with ophthalmological conditions. Ethical considerations are approached from the principles of Beauchamp and Childress, especially regarding the principle of justice, in order to provide health professionals in this field with arguments for medical and ethical decisions that benefit the healthcare and access to medicines for patients with ophthalmological conditions.

[ISO 9001:2015 Certification in Quality Management]. / Zertifizierung des Qualitätsmanagements nach DIN EN ISO 9001:2015.

Quality management improves the structures, processes and results of organizations of all kinds. Many practices and clinics have their existing quality management system certified according to ISO 9001, (e.g., to check their own quality management system or to obtain a testimonial against third parties). The latest version ISO 9001:2015 contains some changes, both structurally and in terms of content. These changes can be met with reasonable efforts. An ISO 9001:2015 certification represents a value for your organization, but these advantages are often not directly measurable.

Malpractice Litigation in Pediatric Ophthalmology.

IMPORTANCE: Understanding outcomes of pediatric malpractice litigation allows ophthalmologists to gain insight into how to best care for patients and prevent such litigation. OBJECTIVES: To report and analyze the causes and outcomes of ophthalmology medical malpractice litigation involving patients younger than 18 years. DESIGN, SETTING, AND PARTICIPANTS: The WestLaw database was reviewed from April 1 to 30, 2015, for ophthalmology-related lawsuits, including settlements and trial verdicts, in the United States from January 1, 1930, to December 31, 2014. Search terms included ophthalmology or ophthalmologist and malpractice anywhere in the retrieved documents. Cases in which the plaintiffs were younger than 18 years at the time of the inciting event were included. Pediatric cases were compared with adult cases. MAIN OUTCOMES AND MEASURES: Pediatric malpractice case outcomes and settlement amounts. RESULTS: Sixty-eight ophthalmology malpractice cases involving plaintiffs younger than 18 years were included in the study. Thirty-five cases (51.5%) were resolved via jury trial. Of these 35 cases, verdicts in favor of the plaintiff were issued in 17 pediatric cases (48.6%), compared with 168 of 584 adult cases (28.8%) (difference, 33%; 95% CI, -24% to 64%; P = .01). The 17 cases that resulted in verdicts in favor of the pediatric plaintiff had a mean jury award of $4 815 693 (median, $883 281; range, $147 765-$42 061 690). Nine of the total 68 cases (13.2%) resulted in a settlement, with mean adjusted indemnities of $1 912 738 (median, $1 377 689; range, $92 070-$8 493 086). The remaining 24 cases (35.3%) involved appellate rulings, pretrial and posttrial relief rulings, and 1 bench verdict. Jury awards were higher in pediatric vs adult cases (difference, $3 422 134; 95% CI, -$3 422 134 to $8 731 916; P = .002), as were indemnity payments (difference, $1 186 757; 95% CI, -$69 074 to $3 342 588; P = .003). Cases involving legal blindness were more likely to result in verdicts in favor of the plaintiff (difference, 60.5%; 95% CI, -1% to 62%; P = .30). Common clinical scenarios in cases of litigation were traumatic ocular injury (15 [22.1%]), retinopathy of prematurity (12 [17.6%]), and endophthalmitis (6 [8.8%]). CONCLUSIONS AND RELEVANCE: Malpractice litigation involving pediatric patients was more likely to be resolved in favor of the plaintiff and was associated with higher monetary awards than was adult litigation. Cases involving retinopathy of prematurity resulted in the highest payments to plaintiffs, and cases involving legal blindness and/or endophthalmitis were more likely to be resolved in favor of the plaintiff. This information may give pediatric ophthalmologists insight into the situations and conditions that commonly lead to litigation.

Twenty-five years of professional liability in pediatric ophthalmology and strabismus: the OMIC experience.

PURPOSE: To summarize the claims statistics of the Ophthalmic Mutual Insurance Company (OMIC) in the field of pediatric ophthalmology and strabismus (POS). METHODS: Internal OMIC case summaries and defense counsel case evaluations of all claims in the field of POS closed between December 1, 1988, and February 19, 2013 were retrospectively analyzed. RESULTS: A total of 140 claims were closed over the 25-year study period, of which 44 were closed with an indemnity payment. Claims related to strabismus and retinopathy of prematurity (ROP) were most common, and claims related to ROP resulted in the highest indemnity and expense payments. Issues related to follow-up represented the most significant risk factor among system-related claims. CONCLUSIONS: Claims in pediatric ophthalmology and strabismus were infrequent but associated with three times higher average indemnity payments relative to all claims paid by OMIC during the course of the study.

[Essential aspects of ophthalmological expert assessment in private accident insurance]. / Wesentliche Aspekte der augenärztlichen Begutachtung für die private Unfallversicherung.

Commissions for an expert assessment place basically high demands on commissioned eye specialists because this activity differs from the normal routine field of work. In addition to assessing objective symptoms and subjective symptomatics in a special analytical manner, eye specialists are expected to have knowledge of basic legal terminology, such as proximate cause, evidence and evidential value. Only under these prerequisites can an ophthalmologist fulfill the function of an expert with a high level of quality and adequately adjust the special medical ophthalmological expertise to the requirements of the predominantly legally based clients commissioning the report and oriented to the appropriate valid legal norms. Particularly common difficulties associated with making an ophthalmological expert report for private accident insurance, e.g. determination of the reduction in functional quality, consideration of partial causality and assessment of diplopia are discussed.

Clinical negligence in ophthalmology: fifteen years of national health service litigation authority data.

OBJECTIVE: To categorize and understand the reasons behind ophthalmic clinical negligence claims in the National Health Service and how such claims can be avoided. DESIGN: Retrospective analyses of all ophthalmic clinical negligence claims between 1995 and 2009 were carried out. Data were obtained from the National Health Service Litigation Authority through the Freedom of Information Act. Claims were classified according to ophthalmic subspecialty, mean payment per subspecialty, severity, paid-to-closed ratio, and cost. PARTICIPANTS: One thousand two hundred fifty-three ophthalmology-related claims occurring from 1995 through 2009. Of these, 963 claims were closed over the 15-year period. Eighty-four were excluded because of insufficient case data. INTERVENTION: Retrospective analysis of all public sector ophthalmology litigation claims over a 15-year period in England. MAIN OUTCOME MEASURES: Subspecialty pertaining to claim, mean payment per claim, and severity of outcome of clinical incident. RESULTS: Nine hundred sixty-three claims were closed over a 15-year period, of which 67% resulted in payment. The total cost of claims was £32.1 million ($50.3 million), with a mean payment per claim of £33 300 ($52 300). The specialties with the highest mean payment per claim were neuro-ophthalmology and pediatric ophthalmology. Cataract subspecialty had the highest number of claims, accounting for 34% of all claims. CONCLUSIONS: Overall, the number of litigation claims in ophthalmology is low, relative to the high volume of outpatient and surgical workload.